Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chemotherapy Induced Anemia

In brief

The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).

Key facts

Study ID

NCT00931606

Run by

Merck Sharp & Dohme LLC

People needed

30

Starts

2009-06-01

Expected to finish

2010-11-18

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy.
• Has evidence of metastatic breast cancer with a minimum of one lesion per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v 1.1) criteria.
• Is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine.
• Has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study intervention administration.
• ≥ 30 days elapsed (from Day 1) since previous treatment with an erythropoiesis stimulating agent (ESA) (including treatment with intravenous (IV) iron) for chemotherapy induced anemia.
• ≥ 7 days elapsed (from Day 1) since the last red blood cell (RBC) transfusion and receipt of ≤ 2 units of blood in the past 30 days.
• Life expectancy of ≥ 6 months.

You may not qualify if…

• Has had prior radiation therapy to > 20% of the whole skeleton.
• Has had > 5 prior chemotherapy treatment regimens for metastatic breast cancer.
• Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding.
• Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder.
• Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher.
• Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months.
• Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy < 6 months prior to Day 1.
• Has a diagnosis of a myeloid malignancy or known history of myelodysplasia.
• Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ).
• Has had administration of IV antibiotics or febrile (temperature elevation > 38 ° C) within 14 days of Day 1.
• Has uncontrolled hypertension.
• Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C.
• Has clinically significant iron (transferrin saturation < 20%), vitamin B12, or folate deficiency.
• Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia.
• Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1).
• Has received treatment with another investigational drug or device within 1 month prior to Day 1.
• Is pregnant or lactating.
• Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.
• Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).

Where it is running

• Investigative Site — Sedona, Arizona, United States
• Investigative Site — Hot Springs, Arkansas, United States
• Investigative Site — Beverly Hills, California, United States
• Investigative Site — Corona, California, United States
• Investigative Site — Fountain Valley, California, United States
• Investigative Site — Montebello, California, United States
• Investigative Site — Riverside, California, United States
• Investigative Site — Denver, Colorado, United States
• Investigative Site — Boynton Beach, Florida, United States
• Investigative Site — Hinsdale, Illinois, United States
• Investigative Site — Evansville, Indiana, United States
• Investigative Site — Wichita, Kansas, United States
• Investigative Site — Baltimore, Maryland, United States
• Investigative Site — Grand Rapids, Michigan, United States
• Investigative Site — Tupelo, Mississippi, United States
• Investigative Site — Kansas City, Missouri, United States
• Investigative Site — Nyack, New York, United States
• Investigative Site — Goldsboro, North Carolina, United States
• Investigative Site — High Point, North Carolina, United States
• Investigative Site — Winston-Salem, North Carolina, United States
• Investigative Site — Bismarck, North Dakota, United States
• Investigative Site — Middletown, Ohio, United States
• Investigative Site — Philadelphia, Pennsylvania, United States
• Investigative Site — Charleston, South Carolina, United States
• Investigative Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.